There is growing concern in the UK over how the value of vaccinations is assessed. Indeed the Joint Committee on Vaccination and Immunisation has already ordered a working group to look at current methodologies. PharmaTimes speaks to Dr John Porter, Medical Director, Novartis Vaccines, about the issue.

PT: Is the current system used to assess the value of vaccinations in the UK fit for purpose?

JP: In short: No. Clearly as a manufacturer Novartis has a vested interest in ensuring that the system rewards innovation and recognises the contribution vaccines make to public health. 

- The JCVI itself has publicly questioned the appropriateness of the current system for assessment of vaccinations and has instigated the formation of a working group to examine this.

PT: What are the key flaws in how vaccines are currently assessed?

JP: The way vaccines are currently assessed significantly undervalues their true public health benefits and underestimates the potentially devastating impact of the diseases they prevent. 

- Vaccination is a long-term public health strategy which often takes several years to reach its full health impact; for this reason it is inappropriate that vaccines are evaluated in the same way as therapeutic drugs which usually provide an immediate effect. 

- The JCVI's cost-effectiveness methodology relies heavily on assessing the impact of a disease and its after-effects; however, with a rare but aggressive disease like meningococcal disease, there are wide variations in the data available (e.g. disease prevalence rates) which in turn have a profound effect on the results of the assessment.

- For example, when it comes to the JCVI's evaluation of Bexsero, a fundamental flaw was that it ignored the emotional toll of MenB on families and the lost societal contributions from those deceased and debilitated as a result of the disease. 

PT: Bexsero was recently recommended for inclusion on the National Immunisation Programme by JCVI, but was initially rejected on cost-effectiveness grounds despite the same evaluation methodology being used - what are your thoughts on this? 

JP: Bexsero is the result of 20 years of pioneering research and is the first vaccine to offer broad protection against a disease that affects an estimated 33 individuals every week in the UK. The JCVI's interim decision to not recommend Bexsero was therefore extremely disappointing for families across the UK and for Novartis.

- We believe that the JCVI methodology is flawed and the results of cost effectiveness assessments are unpredictable and vary widely.  

- In the case of Bexsero, the methodology used by the JCVI to assess cost-effectiveness of the vaccine was shown to be very sensitive to a number of factors that had the potential to change the results of the assessment significantly. 

- After a lengthy pathway to receiving a positive JCVI recommendation for Bexsero in March 2014, the Department of Health has now begun negotiations with Novartis to procure Bexsero for an infant National Immunisation Programme.

PT: Is there a danger of pharma avoiding vaccines research because of the inconsistencies in evaluation and delays in market access?

JP: Absolutely, when you consider the investment and time that is required to develop and market a vaccine – companies need some assurance that their efforts are fairly rewarded, and without appropriate evaluation this will not happen. 

- A decade ago when the clinical trials for Bexsero were initiated, MenB was more prevalent in the UK. Due to the highly cyclical nature of the disease, levels have since declined. However the experience of measles and pertussis shows us that the burden of vaccine preventable disease can increase swiftly and unpredictably; continued investment into vaccines is therefore essential to ensure that science stays ahead of disease epidemiology.

- Parallels between this and the current situation in the field of antibiotics, which is experiencing a worrying shortfall in investment, are striking. 

- The UK has an excellent history in delivering breakthrough national vaccination programmes and it would be a shame to see this come to an end. 

PT: What can be done to address these issues?

JP: A reassessment of the way vaccines are valued and the benefits that they deliver to society is much needed. We welcome the JCVI's decision to form a working group to reassess current modelling methods and look forward to contributing to this process, and seeing the results.